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The Centers for Medicare and Medicaid Services (CMS) has called this meeting to consider the currently available evidence regarding the impact of labeled and unlabeled use of autologous cellular immunotherapy treatment on health outcomes of patients with metastatic prostate cancer.

As described on the FDA website at http://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm213559.htm, “PROVENGE® (Sipuleucel T, APC8015) is an autologous cellular immunotherapy product consisting of peripheral blood mononuclear cells (PBMCs) obtained from patients by leukapheresis and activated in vitro with a recombinant fusion protein (prostatic acid phosphatase fused with GM-CSF). FDA will require the sponsor to complete a post marketing study to evaluate the risk of stroke in patients who receive sipuleucel-T.”

Public attendees, who have contacted the executive secretary prior to the meeting, will address the panel and present information relevant to the agenda. Speakers are asked to state whether or not they have any financial involvement with manufacturers of any products being discussed or with their competitors and who funded their travel to this meeting.

10:50 – 11:05 AM

Open Public Comments

Public Attendees who wish to address the panel will be given that opportunity

11:05 – 12:00 PM

Questions to Presenters

12:00 – 1:00 PM

LUNCH (on your own)

1:00 – 2:00 PM

Initial Open Panel Discussion: Dr. Goodman

2:00 – 3:00 PM

Formal Remarks and Voting Questions

The Chairperson will ask each panel member to state his or her position on the voting questions

For all voting questions, the health outcomes of interest are: overall survival, control of disease-related symptoms, and the avoidance or minimization of the burdens to patients associated with anticancer therapy. The comparator is the management that the patient would otherwise have received.

For the voting questions, use the following scale identifying level of confidence - with 1 being the lowest or no confidence and 5 representing a high level of confidence.

How confident are you that there is adequate evidence to determine whether or not the use of autologous cellular immunotherapy treatment of asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer significantly improves:

Overall survival?

1 — 2 — 3 — 4 — 5

Control of disease-related symptoms?

1 — 2 — 3 — 4 — 5

Avoidance or minimization of the burdens associated with anticancer therapy while maintaining overall survival and control of disease-related symptoms?

1 — 2 — 3 — 4 — 5

Note: Questions 2 -6 should be addressed only for those outcomes under question 1 where the panel is confident that there is at least intermediate confidence (mean vote of 2.5) that there is adequate evidence to make the determination of improvement.

How confident are you that there is adequate evidence to conclude that autologous cellular immunotherapy treatment significantly improves overall survival in patients with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer?

1 — 2 — 3 — 4 — 5

How confident are you that there is adequate evidence to conclude that autologous cellular immunotherapy treatment significantly improves control of disease-related symptoms in patients with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer?

1 — 2 — 3 — 4 — 5

How confident are you that there is adequate evidence to conclude that autologous cellular immunotherapy treatment significantly improves the avoidance of the treatment burdens (e.g., access, delivery, or side-effects) associated with anticancer therapy in patients with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer?

1 — 2 — 3 — 4 — 5

How confident are you that these conclusions are generalizable to unlabeled use in:

Patients whose prostate cancer has not metastasized?

1 — 2 — 3 — 4 — 5

Patients who have metastatic, castrate resistant disease and symptoms more severe than minimally symptomatic?

1 — 2 — 3 — 4 — 5

Patients who have metastatic prostate cancer but who have not failed hormonal therapy?

1 — 2 — 3 — 4 — 5

How confident are you that these conclusions are generalizable to:

Community based settings?

1 — 2 — 3 — 4 — 5

Patients belonging to demographic groups that may have been under-represented in the enrolled clinical trial populations?

1 — 2 — 3 — 4 — 5

Discussion Questions

Do you believe that there is adequate evidence to identify patients who are more likely or less likely to respond favorably to autologous cellular immunotherapy treatment based on pretreatment evaluation of any of the following factors?